FDA Radiology AI Devices

RadioLens v1.0 by Synapsica is a medical image management and processing system that allows radiologists and medical practitioners to view, analyze, and report on DICOM-format radiology images. The software includes an AI module called SpindleX for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. This helps clinicians by providing quantitative measurements and detailed reports, enhancing diagnostic accuracy and efficiency in spinal injury assessment.

Annalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.

MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.

DTX Studio Clinic 3.0 is an AI-powered software tool designed to assist dentists in detecting dental conditions such as caries, bone loss, periapical radiolucency, root canal filling deficiencies, discrepancy at the margin of restorations, and calculus from intraoral radiographs. It supports review of bitewing and periapical radiographs in patients aged 15 and older, providing highlighted areas of suspicion to aid clinical assessment and diagnosis.

Overjet Caries Assist is an AI-powered software that helps dentists detect and segment dental caries (tooth decay) on bitewing and periapical X-ray images. It provides computer-generated annotations highlighting potential caries to support dentists' diagnosis, improving sensitivity in caries detection. It operates by processing dental radiographs using machine learning models and presenting annotated images in a viewer interface for the dentist. This assists dentists but does not replace professional judgment.

MPXA-2000 is a software tool intended for cardiologists and radiologists to automatically analyze X-ray angiographic images of the coronary arteries. It uses deep learning and computer vision algorithms to segment blood vessels, classify vessel types, quantify vessel dimensions, and support clinical decisions related to coronary artery disease. The software provides validated, reproducible quantitative results to aid in diagnosis and treatment evaluation, with results available for review and export.

FlightPlan for Embolization by GE Medical Systems SCS is a software application that processes 3D X-ray angiography images to help clinicians visualize blood vessels during the planning phase of embolization procedures. It uses AI-powered algorithms to automatically segment vasculature and define root points, assisting physicians in better treatment planning. This enhances clinical decision-making but is not intended for use during the delivery of therapy itself.

Viz AAA is an AI-powered software device designed to analyze CT angiogram images of the abdomen to detect suspected abdominal aortic aneurysms. It helps specialists prioritize patient studies by flagging those with potential aneurysms, improving workflow efficiency in clinical settings. The software provides non-diagnostic preview images and emphasizes that diagnostic decisions remain with treating specialists.

NeuroRPM is a software application for the Apple Watch that uses machine learning to analyze motion sensor data to quantify motor symptoms like tremor, bradykinesia, and dyskinesia in adult Parkinson's disease patients. It helps clinicians remotely monitor symptom presence every 15 minutes, supporting both clinic and home use for improved patient management.